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News

EU expresses "high concern" for bisphenol A

18/09/2017 - François-Xavier Branthôme - Lire en français
Bisphenol A: EU proposal for a new SML
Final steps before a public inquiry on applicable rules


April 2017: Experts dismiss new study showing dangers of BPA
New research published in the spring by Stanford University indicates that exposure to BPA during pregnancy in mice leads to dysfunction of the immune system and development of diseases such as multiple sclerosis. The dangers of BPA to infants and pregnant mothers are well known; last year, the Dutch president of the Council of the EU sent an “urgent” request to EFSA to again re-evaluate BPA following a report by the Dutch National Institute for Public and Environmental Affairs (RIVM) indicating the threshold for dangerous exposure levels should be set far lower.

The new findings at Stanford would appear to provide more evidence that any exposure to BPA during pregnancy is dangerous, but notable experts have said the results are "at best phenomenology and of little if any relevance to human health".
Dr. Warren Foster, professor of obstetrics and gynecology at the school of biomedical engineering, McMaster University, explained that the levels of BPA administered to mice in the study was significantly higher – conservatively 60 000 times greater – than levels to which humans are exposed. Professor Richard Sharp of the MRC Centre for Reproductive Health at the University of Edinburgh agreed with Foster: “Based on the exposures used for these mice studies, there would be no comparable autoimmune health risk to humans.”
Despite expert opinion, the EU published draft regulations for stricter limits on BPA.

June 2017: BPA is considered "high concern" by Europe
The European Chemicals Agency (ECHA) announced on 16 June that bisphenol A (BPA) has been listed as a "substance of the very high concern" (SVHC) for its endocrine disruption properties, which are likely to have major adverse effects on human health, raising concerns to the same level as substances that are carcinogenic, mutagenic or reprotoxic. 
Except for the United Kingdom and Finland, who abstained, all member states voted favorably to the classification proposal submitted by France.
"This decision will result in the obligation for the industry to notify ECHA of the presence of the substance in all items manufactured or imported, and to inform buyers of the presence of BPA in an item," stated the ANSES (French governmental agency dealing with sanitary safety in food, the environment and at work) in a press release. It also means that BPA could be subjected to specific authorization as a substance, conditioning its use by the granting of a temporary and renewable authorization.”
A subtle but important distinction between danger and hazard
Since the first studies led by the Canadian health and safety agency at the end of the 2000s, many studies and surveys have been carried out, often with contradictory results, feeding the debates carried out by health authorities in a number of countries and justifying the recommendations aiming to reduce the exposure to BPA of the general population. A number of bio-monitoring studies seem to indicate a drop in exposure of the population, but the substance remains detectable in approximately 95% of the inhabitants of Western countries.
However, classifying BPA as "high concern" only applies to the danger presented by the substance itself; it says nothing about the hazard presented for the population at currents levels of exposure.

July 2017: call for feedback
This question remains at the heart of a disagreement between the ANSES and the EFSA. The EFSA remains firm in its decision to include BPA on the ECHA list, maintaining the decision it took in October 2016 stating that there is insufficient proof to reach conclusions regarding human health. EFSA’s risk assessment maintains that a tolerable daily intake (TDI) for BPA of 4 µg per kilogram of body weight (µg/kg bw/day) is safe.

In its evaluation, EFSA concluded that there is no consumer health risk from current BPA exposure. On endocrine disruption, EFSA's expert panel concluded that ''based on the WHO criteria, it is not possible to conclude that BPA is an endocrine disruptor."

At the beginning of July, EFSA called for feedback on its approach to evaluate the toxicity of BPA. The draft describes potential health effects (e.g., reproduction, mammary, nervous system) and provides questions for each type of effect, as well as approaches for weighing and integrating evidence, establishing a full TDI and assessing uncertainties.
EFSA said toxicity would be re-evaluated when results of research by the US National Toxicology Program (expected to become available in 2017) were available. EFSA is re-evaluating the toxicity of BPA with an assessment due to start in 2018 by the CEF panel (on Food Contact Materials, Enzymes, Flavourings and Processing Aids). The review will also include other studies judged relevant and published since the December 2012 cut-off point for the last review of BPA safety.

September 2017: specific migration limits (SML) reviewed
At the end of August, the European Commission opened a comment period on draft regulation to crack down on BPA limits. It creates a new specific migration limit (SML) of 0.05 mg/kg food for BPA migrating from varnishes or coatings applied to materials or articles intended for food contact. Current levels allow an SML of 0.6 mg of BPA per kg of food (mg/kg).
"[To] ensure that the business operators have sufficient time to adjust their manufacturing processes to comply with the restrictions and to reduce the administrative and financial burden that such adjustments may entail, it is appropriate to defer the application of this regulation – and to permit materials and articles which have been lawfully placed on the market before the date of application of this regulation to remain on the market – until the exhaustion of stocks," said the Commission.
 
Feedback is open until 20 September at:
https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-4140854_en


 
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